By definition, ostomy refers to a surgical procedure creating an opening in the body for the discharge of body wastes. Certain diseases of the bowel or urinary tract involve removing all or part of the intestine or bladder. This creates a need for an alternate way for feces or urine to leave the body. An opening is surgically created in the abdomen for body wastes to pass through. The result of the surgical procedure is called an ostomy. The opening that is created at the end of the bowel or ureter is called a stoma, which is pulled through the abdominal wall. The size of a stoma depends on the individual as well as the organ it was made from. Stomas are of various widths and heights (from the abdominal wall). As used in the specification herein the segment that is outside the abdomen is referred to as the stoma wall.
Different types of ostomy are performed depending on how much and what part of the intestines or bladder is removed.
The three most common types of ostomies are:
1. colostomy;
2. ileostomy; and
3. urostomy.
A colostomy is a when a small portion of the colon (large intestine) is brought to the surface of the abdominal wall to allow stool to be eliminated. A colostomy may be temporary or permanent. A permanent colostomy usually involves the loss of the rectum. A colostomy might be performed due to cancer, diverticulitis, colitis, imperforate anus, Hirschsprung's disease, or trauma to the affected area.
An ileostomy is an opening created in the small intestine to bypass the colon for stool elimination. The end of the ileum, which is the lowest part of the small intestine, is brought through the abdominal wall to form a stoma. An ileostomy might be performed due to ulcerative colitis, Crohn's disease, or familial polyposis.
A urostomy is a surgical procedure that diverts urine away from a diseased or defective bladder. Among several methods to create the urostomy, the most common methods are called an ileal or large intestinal conduit. Either a section at the end of the small intestine (ileum) or a section of the large intestine is isolated from the fecal stream and relocated surgically to form a stoma for urine to pass out of the body. Other common names for this procedure are ileal loop or colon conduit. A urostomy may be performed due to bladder cancer, spinal cord injuries, malfunction of the bladder, and birth defects such as spina bifida.
Since colostomy, ileostomy, and urostomy bypass the sphincter muscle there is no voluntary control over bowel movements or urination and an external pouch must be worn to catch the discharge.
The skin around the stoma, called the peristomal skin, must be protected from direct contact with discharge. The discharge can be irritating to the stoma since it is very high in digestive enzymes or urinary products. The peristomal skin should be cleansed with plain soap and rinsed with water at each change of the pouch.
The stoma can change in size due to weight gain/loss or several other determining factors. To ensure proper fit of the discharge pouch conventional practice dictates the stoma should be measured each time supplies are purchased.
People with ostomies can be prone to certain types of skin infections. Skin irritations or rashes around the stoma may be caused by leakage due to an improperly fitted (cemented) barrier seal. Correctly fitting the barrier and carefully cleaning the skin around the stoma after each change are the best ways of preventing skin irritation.
Conventional pouching systems include a one-piece or two-piece system. Both kinds include a skin barrier/wafer (“faceplate” in older terminology) and a collection pouch. The pouch (one-piece or two-piece) attaches to the abdomen by the skin barrier and is fitted over and around the stoma to collect the diverted output, either stool or urine. The barrier/wafer is designed to protect the skin from the stoma output and to be as neutral to the skin as possible.
Colostomy and Ileostomy pouches are either open-ended, requiring a closing device (traditionally a clamp or tail clip); or closed and sealed at the bottom. Open-ended pouches are called drainable and are left attached to the body while emptying. Closed end pouches are most commonly used by patients who can irrigate or by patients who have regular elimination patterns. Closed end pouches are usually discarded after one use.
Typically, two piece systems allow changing pouches while leaving the barrier/wafer attached to the skin. The wafer/barrier is part of a “flange” unit. The pouches utilize multiple methods to attach mechanically to a mating piece on the flange. A common connection mechanism consists of a pressure fit snap ring, similar to that used in Tupperware™.
One-piece systems consist of a skin barrier/wafer and pouch joined together as a single unit. These provide greater simplicity than two-piece systems but require changing the entire unit, including skin barrier, when the pouch is changed.
Both two-piece and one-piece pouches can be either drainable or closed.
A typical ostomy barrier is essentially a large adhesive patch, generally 4″×4″, with a center hole which varies in size relative to the outer diameter of the stoma, typically ranging from ¼″ to 3″ diameter center hole. The center hole diameter sizes are either fixed or cut to size by the user. The barrier is three layers thick, with a cloth face, a heavy 3″ ring of thick adhesive and a sheet of plastic approximately 1/64″ thick. After application, the barrier is expected to remain on the body from 3 to 5 days.
Current barrier seals require that the patient cut the ring in the center of the barrier to a size that fits his or her stoma. This often leaves a jagged edge on the seal, which irritates the stoma causing pain, irritation and bleeding. The invention ostomy barrier seal requires no cutting. It is flexible and automatically sizes, shapes and seal itself along the stoma wall and causes no discomfort.
Further, currently known ostomy barriers require an adhesive glue to make the barrier adhere tightly to the skin around the stoma wall and prevent leakage. U.S. Patent Publication 2011/0172619A1 to Argent describes a device for use with an ostomy appliance that has an opening surrounded by a cylindrical peripheral wall with a flange part. The device is made of a polyurethane material known as Alphathane™ and is said to be elastically deformable. The Argent device comes in various sizes depending on the size of the user's stoma, however, it does not take into account movement and changes in the stoma which depending on activity changes the stoma height and width. The Argent device fails to accommodate these changes thus increasing the incidence of leakage of waste.
One of the major issues with current barriers is that body waste leaks under the barrier glue, irritating the skin close to the stoma and under the adhesives. This causes the adhesive to weaken creating further leakage of body waste allowing the whole barrier to loosen. This can cause spillage and accidents.
The invention overcomes these obstacles by sealing itself around the stoma wall without the use of any further glue, adhesive or scissor cutting. The invention is self-aligning, flexible with stoma movement and much more comfortable to wear than any known device. It fits the stoma in a manner similar to a turtleneck.
The invention provides a more secure fit around the stoma eliminating the need for glue/adhesive currently required (and the resulting skin irritation experienced) when using existing ostomy barriers. It is well known that it is difficult for ostomy patients, after a wearing period, to remove all the glue from the skin around the stoma. Soap and water and light scrubbing on the skin is necessary. This is not only time consuming but is irritating and causes ongoing sensitivity in the area as well as discomfort. All the glue must be removed completely from the skin before new application of the glue and a new barrier applied. The invention overcomes these disadvantages by eliminating the need for any glue/adhesives and provides a mechanical, more comfortable seal.
The invention is more convenient to use than current products on the market. In most cases, ostomy patients require a mirror to enable them to see where the stoma is for positioning the barrier. Most public restrooms do not provide shelves to place supplies and a mirror while applying or removing barriers in privacy. If leakage occurs while patients are outside the home, most patients are embarrassed and feel pressured to return home to address the problem. The ease of application and self-fitting nature of the invention barrier seal facilitates greater peace of mind, mobility and flexibility in patient's going about their daily activities.
Advantage of the present invention device and related method and system is in the provision of an ostomy barrier seal that provides a flexible, self-adjusting seal to compensate for out of round, height center line and angular variants of stomas. The invention functions as a mechanical seal providing better protection against leakage and prevents irritation of the stoma and surrounding skin than the glue affixed to current barriers in the market. The invention is more comfortable and a more convenient solution than what is currently available.
The invention provides a soft seal around the stoma of the individual and takes into account variations within a number of sizes and allows for easy application. It eliminates the need for additional accessory products and makes for a more comfortable and secure fit on the user.
The invention eliminates the conventional method of scissor cutting a hole in the barrier to fit the stoma, as well as the elimination of cement, permitting a faster installation of the barrier. The self-aligning feature makes the use of a sight mirror unnecessary.
A general object of the invention is to provide an ostomy barrier seal that is a flexible, self-adjusting seal adapted to fit around a user's stoma without the need for any adhesive or other cement to ensure a sufficient seal. The barrier seal is made of flexible material, includes an opening to allow protrusion of the stoma, and is attached to a barrier. In an alternate embodiment the ostomy barrier seal may be attached directly to the user's skin.
The invention barrier seal may be used with conventional barriers which comprise a cloth or woven backing with an adhesive applied to the body side. Both the body side and the pouch side of the barrier are substantially flat. A plastic ring for coupling to an ostomy bag is located on the pouch side of the barrier and surrounds the outer periphery of the flexible, self-adjusting barrier seal.
An object of the invention is its easy placement on the user without using a mirror.
Yet another object of the invention is that it eliminates the need for glue around the stoma which not only irritates the stoma and skin, but must be removed and reapplied after each application.
Another object of the invention is to properly place a barrier device on ostomy patients which prevents irritation and bleeding.
Yet another object of the invention is to provide a translucent plastic material barrier seal which permits visual confirmation of the seal along the stoma wall.
A further object of the invention is its self-aligning and continual sealing ability to accommodate stoma movement.
Another object of the invention is its comfort to the user in the elimination of pressure and discomfort.
Another object of the invention is in the reduction of the number of sizes required to accommodate different stoma widths.